Ardelyx, Inc. - ARDX STOCK NEWS

Ardelyx, along with AAKP and NMQF, has filed a lawsuit against the U.S. Department of Health and Human Services and CMS. The lawsuit challenges CMS's plan to include XPHOZAH and other oral-only phosphate lowering therapies (PLTs) in the End-Stage Renal Disease Prospective Payment System (ESRD PPS).

The plaintiffs argue that this move violates statutory authority under MIPPA and will negatively impact patient choice and timely access to important medications. They seek to prevent CMS from including XPHOZAH in the ESRD PPS and eliminating coverage under Medicare Part D starting January 1, 2025.

XPHOZAH, approved by the FDA in October 2023, is a first-in-class phosphate absorption inhibitor for adults with chronic kidney disease on dialysis. The lawsuit aims to protect dialysis patients' access to new therapies and maintain incentives for developing innovative medicines in this underserved therapeutic area.

Ardelyx has decided not to apply for the CMS TDAPA for its phosphate absorption inhibitor, XPHOZAH (tenapanor), to maintain patient access. The company supports bipartisan legislation that aims to extend the exclusion of oral-only medications from the CMS Prospective Payment System. This decision follows Ardelyx's analysis of the CMS policy, determining that including XPHOZAH in the Medicare PPS would significantly restrict its usage and hinder patient access. XPHOZAH, approved by the FDA in October 2023, is the only therapy for patients with inadequate response to phosphate binders, offering a unique mechanism to reduce serum phosphorus in CKD patients on dialysis. A conference call is scheduled for July 2, 2024, at 8:00 AM ET to discuss the announcement.

Ardelyx (Nasdaq: ARDX) presented new data on the educational needs related to the management of irritable bowel syndrome with constipation (IBS-C) across healthcare disciplines at the 2024 American Association of Nurse Practitioners (AANP) Annual Conference.

The findings, based on a survey of 410 healthcare professionals, highlighted significant differences in diagnostic criteria, testing methodologies, referral tendencies, and pain assessment approaches between nurse practitioners/physician assistants and physicians.

Additionally, the data showed that gastroenterology specialists are more likely to prescribe medications like linaclotide, plecanatide, or tenapanor for IBS-C patients avoiding social events due to discomfort, whereas primary care physicians prefer neuromodulators.

These insights underscore the need for tailored educational programs to address the specific requirements of various healthcare roles.

Ardelyx (Nasdaq: ARDX), a biopharmaceutical company, announced on May 30, 2024, that its compensation committee granted stock options and Restricted Stock Units (RSUs) to 23 new non-executive employees on May 23, 2024. A total of 210,000 stock options and 179,050 RSUs were awarded. The options have an exercise price of $7.44 per share, reflecting the closing price on the grant date. Both stock options and RSUs vest over four years with specific vesting schedules. These grants were made under Nasdaq Listing Rule 5635(c)(4) to incentivize employment.

Ardelyx, a biopharmaceutical company (Nasdaq: ARDX), will participate in the 2024 Jefferies Global Healthcare Conference. Michael Raab, President and CEO, alongside Justin Renz, Chief Financial and Operations Officer, will engage in a fireside chat on June 5, 2024, at 10:00 A.M. Eastern Time in New York City. The event will be accessible via live webcast on the Ardelyx website, with a replay available for 30 days after the event.

Ardelyx, a biopharmaceutical company, announced additional positive clinical data for IBSRELA® (tenapanor) at the 2024 Digestive Disease Week Conference in Washington, D.C. IBSRELA, approved by the FDA for treating irritable bowel syndrome with constipation (IBS-C) in adults, demonstrated a clinically meaningful response in a Phase 3 post hoc analysis. The treatment proved effective regardless of prior use of other IBS-C medications and showed comparable or more pronounced efficacy in Hispanic patients. These findings further support IBSRELA's potential as a novel treatment option for IBS-C.

Ardelyx (Nasdaq: ARDX) presented new data on XPHOZAH® (tenapanor) at the NKF 2024 Spring Clinical Meetings. The drug, approved by the FDA, helps reduce serum phosphorus in CKD patients on dialysis. Presented posters showed improved phosphate control when tenapanor was added to existing treatments, effective results across various age groups, and increased patient adherence due to improved treatment perception. These findings, highlighting XPHOZAH's unique mechanism of action, were shared during an Exhibitor Showcase discussing hyperphosphatemia management.

Ardelyx, a biopharmaceutical company, announced on May 6, 2024, the granting of stock options and Restricted Stock Units (RSUs) to new non-executive employees. The compensation committee approved options for 26 employees, totaling 511,500 shares, and RSUs for 32 employees, totaling 425,050 shares. The stock options have an exercise price of $9.15 per share, the closing price on the grant date, and vest over four years. RSUs also vest over four years, with specific quarterly vesting schedules. These inducements align with Nasdaq Listing Rule 5635(c)(4) and are part of Ardelyx's 2016 Employment Commencement Incentive Plan.

Ardelyx, Inc. (Nasdaq: ARDX) will present additional data supporting IBSRELA® (tenapanor) for adults with irritable bowel syndrome with constipation at the 2024 Digestive Disease Week Conference. IBSRELA is approved by the FDA to treat IBS-C in adults. The presentation will include posthoc analysis from Phase 3 studies and a Product Theater discussing clinical considerations for managing IBS-C.